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Therapeutic Efficacy of Erbium:YAG Laser in Postpartum Patients With Episiotomy Scars

NCT05793476 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2025-05-02

No results posted yet for this study

Summary

Episiotomy is a planned surgical incision to the perineum and posterior wall of the vagina during the second stage of labor. The fibrotic and sclerotic scar tissue formed as part of the healing process of episiotomies may cause pain. Therefore, episiotomy is associated with sexual dysfunction due to the painful sexual intercourse, chronic pain and infections and scarring in long term. Er:YAG laser is a safe option for the treatment of vulvar pain.

Er:YAG laser is a non-invasive and non-ablative procedure that strengthens the connective tissue in the vaginal wall. It provides controlled thermal energy and causes shrinkage of collagen fibrils of the vaginal epithelium and lamina propria. It also induces neocollagenesis, elastogenesis and neoangiogenesis by temperature change. Er:YAG laser is also an effective modality to treat the scar tissue formed after the mediolateral episiotomy since it is a matter of functionality and esthetics. By tissue remodeling effect Er:YAG laser will improve the scar tissue of episiotomy and ameliorate the vulvar pain.

In this study, the therapeutic effect of Er:YAG laser on the tissue healing of the episiotomy scars and the reduction of vulvar pain.

Conditions

  • Episiotomy Wound
  • Laser
  • Vulvodynia
  • Vulva Pain

Interventions

DEVICE

Fotona Dynamis Er:YAG Laser System

The patient receives 2940 nm Er:YAG Laser (XS Dynamis, Fotona, Slovenia) at intervals of 15-21 days. She receives 3 sessions, in total. 5% Lidocaine cream is applied 30 minutes before each procedure. Each session consists of application of R11 handpiece to the episiotomy scar at Turbo3 Micro Short Pulse mode, with spot size of 2 mm, fluence of 9.5-10 j/cm2, frequency of 2 Hz and 4 pulses per point and 3 passes followed by PS03 handpiece at Basic Long Pulse mode, with spot size of 5 mm, energy of 800 mJ, frequency of 1.4 Hz and 4 pulses per point and 2 passes.

DEVICE

Fotona Dynamis Er:YAG Laser System with Sham handpiece

The same procedure is applied above but with a sham handpiece and parameter presentations masked.

Sponsors & Collaborators

  • Fotona d.o.o.

    collaborator INDUSTRY

  • Istanbul University - Cerrahpasa

    lead OTHER

Principal Investigators

  • Cemal Tamer Erel, Prof. · Istanbul University - Cerrahpasa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-04
Primary Completion
2025-01-01
Completion
2025-01-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05793476 on ClinicalTrials.gov